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Toku Receives CE and UKCA Marks for CLAiR Technology

Toku Receives CE and UKCA Marks for CLAiR Technology

February 07, 2024

Toku announced the acquisition of the CE Mark in Europe and UKCA certification in the United Kingdom for its patented CLAiR technology. This innovation offers a non-invasive method for assessing the risk of cardiovascular disease (CVD) directly at the point of care, utilizing retinal images obtained during routine eye examinations.

The CLAiR technology seamlessly integrates into existing retinal cameras, empowering healthcare professionals to conduct real-time CVD risk evaluations with accuracy akin to traditional gold standard assessments. Unlike conventional methods that often necessitate blood tests and prolonged waiting periods, CLAiR provides swift results, offering a timely and efficient means of identifying elevated cardiovascular risk.

Powered by artificial intelligence, CLAiR meticulously analyzes subtle changes within the retina and its vasculature to pinpoint potential indicators of heightened cardiovascular risk. These findings can be readily shared with a patient's primary care physician, facilitating prompt intervention and personalized preventive measures.

Given the routine nature of retinal imaging in various healthcare settings, including eye care facilities, pharmacies, and primary care clinics throughout the UK and EU, CLAiR holds immense potential to enhance cardiovascular risk assessment. By enabling healthcare providers to proactively identify elevated cardiovascular risk in adult patients lacking a known history of CVD, CLAiR represents a significant advancement in preventive healthcare strategies.

“I believe that a retinal image can be considered the ‘fifth vital’ along with temperature, heart rate, respiration rate, and blood pressure,” Toku CEO Associate Professor Ehsan Vaghefi said in a company news release. “The CE and UKCA marks allow us to bring CLAiR to patients across multiple geographies. In my vision of the future, a retinal image analysis is an integral part of a comprehensive screening for major diseases such as cardiovascular or kidney disease.”

“The eye is the only organ of the body where we can non-invasively view and image blood vessels. The advent of artificial intelligence has enabled analysis of retinal images to predict the occurrence and time course of numerous diseases of the vascular system, including heart attacks and strokes," said Professor John Marshall, the holder of the original patents for refractive surgery and Emeritus Professor of Ophthalmology at both University College London & Kings College, London. "Such early risk identification allows timely modification of lifestyle and even earlier treatment to prevent or delay onset. Toku’s CLAiR algorithm is a major breakthrough in the field of cardiovascular diseases and should result in lifesaving interventions and improved quality of life for innumerable individuals throughout the world.”